MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number KD-650L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Perforation (2001)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the literature titled "risk factors for lymph node metastasis and indication of local resection in duodenal neuroendocrine tumors".The present study aimed to investigate the clinicopathological features of duodenal neuroendocrine tumors (dnets) with a relatively large number of cases and identify the risk factors for lymph node metastasis (lnm).In addition, short- and long-term outcomes of endoscopic resection (er) and laparoscopy and endoscopy cooperative surgery (lecs) were compared to establish the application of local resection for dnets.55 patients with 60 dnets were enrolled; dnets <5 mm were treated with er and those of 5¿10 mm were treated with lecs.Lnm was present in four (8.7%) patients.No significant differences were observed in terms of complication rates.No recurrence was observed in any of the groups.Type of adverse events/number of patients: [endoscopic resection group (n=18)].Intraoperative perforation- 2 patients.[lecs group (n=9)].Abdominal abscess- 1 patient.The authors used 3 olympus devices and did not specify which device was involved with the adverse events: patient identifier (b)(6): gif-q260j.Patient identifier (b)(6): kd-611l.Patient identifier (b)(6): kd-650l.This report is 3 of 3 for patient identifier (b)(6): kd-650l.

Manufacturer Narrative

Correction: e3.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, information from the author, and a correction.New information was added to the following fields: b3, b5, h6, h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

Event Description

In the opinion of the author, the olympus device did not cause or contribute to the reported adverse event.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14602590
• MDR Text Key: 293357392
• Report Number: 8010047-2022-09478
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170265761
• UDI-Public: 04953170265761
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-650L
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SERIAL UNK: GIF-Q260J, ESG-100
• Patient Outcome(s): Required Intervention; Other